FDAFDA · Food and drugs·Recall number Z-1184-2013
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Published May 8, 2013 · Recall initiated: April 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LLC
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
- Lot
- Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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